FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC PLUS
MDR report key: 2253411
·
Received August 3, 2011
Report
- Report Number
- 1824206-2011-04097
- Event Type
- Malfunction
- Date Received
- August 3, 2011
- Date of Event
- July 15, 2011
- Report Date
- July 19, 2011
- Manufacturer
- HILL-ROM INC
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE FIELD TECH ATTEMPTED TO DUPLICATE THE ISSUE WITH (B)(6), THE BED IN TURN ASSIST AND THE TECHNICIAN'S WEIGHT PULLED ON THE BED. HE COULD NOT GET THE BED TO MOVE OFF THE CASTERS AND WAS UNABLE TO DUPLICATE ISSUE. THE TECH INTERVIEWED THE NURSING STAFF AND WAS TOLD THAT THE (B)(6) PT WHEN USING TURN ASSIST CREATED A "ROCKING" MOTION.
Description of Event or Problem · 1
THE ACCOUNT'S ICU DIRECTOR ALLEGEDLY HAD A (B)(6) PT ON THE TOTALCARE BED WHEN THEY USED TURN ASSIST, THE BED TRIED TO TIP TO ONE SIDE AND THE NURSE CAUGHT THE FRAME OF THE BED WITH HER LEG TO KEEP IT FROM TIPPING. THE NURSE BRUISED HER LEG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BARIATRIC PLUS | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |